BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 3221789 · Received July 9, 2013

    Report

    Report Number
    1644019-2013-00069
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ALCON-HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THE CUSTOM PAK LOT SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DEVICE HISTORY RECORD (DHR) REVIEW NOT POSSIBLE. A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. WITHOUT A SAMPLE, A ROOT CAUSE INVESTIGATION CANNOT BE CONDUCTED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NO KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PATIENT DEVELOPED ENDOPHTHALMITIS FOUR DAYS AFTER HAVING A CATARACT EXTRACTION PROCEDURE. CULTURES WERE POSITIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312847 CUSTOM PAK CONVENIENCE KIT KYG ALCON-HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other